search
Back to results

Effect of a Combination Oral Formulation of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate in Patients With Gastro-Esophageal Reflux Disease Not Fully Satisfied With Their Treatment

Primary Purpose

Gastro Esophageal Reflux

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet
Placebo 1100 mg, identically-looking melt in mouth tablet
Sponsored by
SOFAR S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastro Esophageal Reflux

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed and dated informed consent (ICF): a written informed consent must be obtained prior to any study related procedure being performed
  • Male and female out-patients aged 18 to 80 years
  • GERD diagnosis confirmed through a validated questionnaire (GERDQ score ≥ 8).
  • EGD endoscopy performed within 1 year before screening
  • Patients in continuous or intermittent treatment with PPI for at least 1 year and continuously for at least 4 weeks prior to study entry
  • Patients not fully satisfied with current PPI treatment (1-3 score on 5-points Likert scale)

Exclusion Criteria:

  • Dyspeptic patients or patients with overlapping symptoms with GI diseases other than GERD
  • Histological evidence of Barrett's oesophagus > 1 cm in EGD endoscopy
  • Peptic stricture in EGD endoscopy
  • Concurrent findings in the EGD endoscopy that might interfere with the participation to the study (e.g cancer, peptic ulcer) as judged by the investigator
  • Known impaired kidney or liver function at screening
  • Presence of any relevant severe condition or clinically relevant abnormal parameters that in the opinion of the investigator may interfere with the participation to the study
  • Medication use (including H2 antagonists, alginates, baclofen, NSAIDS, prokinetics, antidepressants) that may interfere with GERD symptom assessment within 2 weeks before the start of the study or during the study
  • Pregnancy or breast-feeding
  • Females of childbearing potential not employing adequate contraceptive methods
  • Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable)
  • History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent
  • History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements
  • Treatment with any investigational drug within the previous 30 days

Sites / Locations

  • Diakonie Klinikum GmbH - Jung- Stilling Krankenhaus
  • Klinikum Region Hannover (KRH) Klinikum Siloah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GERDOff Plus

Placebo

Arm Description

Hyaluronic acid + chondroitin sulphate + magnesium trisilicate melt in mouth tablets (1100 mg). 1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks. After three weeks of wash-out period,patients will take either placebo or GERDOff Plus q.i.d. (three after meals, one before resting) for another three weeks.

Placebo melt in mouth tablets (1100 mg). 1 tablet q.i.d. (three after meals, one before resting) for three consecutive weeks. After three weeks of wash-out period, patients will take either placebo or GERDOff Plus q.i.d. (three after meals, one before resting) for another three weeks.

Outcomes

Primary Outcome Measures

Overall patient satisfaction
The percentage of patients with an improvement of at least 2 points in the patient satisfaction measured with a 1 to 5 Likert scale (1 worst satisfaction, 5 best satisfaction)

Secondary Outcome Measures

Change of weekly frequency of each symptom using the Gastro Esophageal Reflux Disease Questionnaire (GERDQ) questionnaire
The reduction of weekly frequency score (points) for each symptom (score from 0 to 3, where higher scores mean a worse outcome) assessed by GERDQ questionnaire. Frequency score (points) for symptom: 0=0 day, 1=1 day, 2=2-3 days, 3=4-7 days; How often did you have a burning feeling behind your breastbone (heartburn)? 0 1 2 3 How often did you have stomach contents (liquid or food) moving upwards to your throat or mouth (regurgitation)? 0 1 2 3 How often did you have a pain in the centre of the upper stomach? 3 2 1 0 How often did you have nausea? 3 2 1 0 How often did you have difficulty getting a good night's sleep because of your heartburn and ⁄ or regurgitation? 0 1 2 3 How often did you take additional medication for your heartburn and ⁄ or regurgitation, other than what the physician told you to take? (such as Tums, Rolaids, Maalox?) 0 1 2 3
Change of weekly global score of symptoms using the Gastro Esophageal Reflux Disease Questionnaire (GERDQ) questionnaire
The reduction of global score of GERQ questionnaire (score from 0 to 18, where higher scores mean a worse outcome). Global score is obtained as sum score of the 6 items detailed in Outcome 2.
Change of the intensity of each symptom using the Reflux Symptom Index (RSI) questionnaire
The reduction of score of each symptom (from 0 to 5, where 0 = No problem and 5 = Severe Problem) assessed by RSI questionnaire Hoarseness or a problem with voice Cleaning throat Excess throat mucus or postnasal drip Difficulty swallowing food, liquids, or pills Coughing after eating or after lying down Breathing difficulties or chocking episodes Troublesome or annoying cough Sensations of something sticking or a lump in the throat Heartburn, chest pain, indigestion or stomach acid coming up
Change of the global score using the Reflux Symptom Index (RSI) questionnaire
The reduction of global score of RSI questionnaire (from 0 to 45, where higher scores mean a worse outcome). Global score is obtained as sum score of the 9 items detailed in Outcome 4.
Assessment of palatability
The score of taste through a 4-point qualitative scale (where 1 - taste as bad as possible, and 4 - taste as good as possible)
Evaluation of the intake of rescue medications
The amount of rescue medications taken

Full Information

First Posted
December 12, 2019
Last Updated
April 11, 2023
Sponsor
SOFAR S.p.A.
search

1. Study Identification

Unique Protocol Identification Number
NCT04202692
Brief Title
Effect of a Combination Oral Formulation of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate in Patients With Gastro-Esophageal Reflux Disease Not Fully Satisfied With Their Treatment
Official Title
Evaluation of the Performance and Safety of an Oral Formulation of Hyaluronic Acid With Chondroitin Sulphate and Magnesium Trisilicate (GERDOff® Plus) in Patients With Gastro-Esophageal Reflux Disease: A Double-blind, Placebo-controlled, Randomized, Cross-over Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 5, 2019 (Actual)
Primary Completion Date
November 23, 2022 (Actual)
Study Completion Date
November 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SOFAR S.p.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a post-market, multi-center, double-blind, placebo-controlled, randomized, cross-over study with GERDOff Plus added on top of the current PPI treatment in patients with GERD. The aim of the study is to evaluate the performance of GERDOff Plus, a class III medical device, consisting in a hyaluronic acid, chondroitin sulphate and magnesium trisilicate, in addition to the PPIs, in patients with GERD not fully satisfied with their current treatment with PPIs. Patients will receive either GERDOff Plus or placebo q.i.d. for 21 days followed by a wash-out period of 3 weeks. After the wash-out period, the patients will receive either placebo or GERDOff Plus respectively

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro Esophageal Reflux

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
double-blind, placebo controlled
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GERDOff Plus
Arm Type
Experimental
Arm Description
Hyaluronic acid + chondroitin sulphate + magnesium trisilicate melt in mouth tablets (1100 mg). 1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks. After three weeks of wash-out period,patients will take either placebo or GERDOff Plus q.i.d. (three after meals, one before resting) for another three weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo melt in mouth tablets (1100 mg). 1 tablet q.i.d. (three after meals, one before resting) for three consecutive weeks. After three weeks of wash-out period, patients will take either placebo or GERDOff Plus q.i.d. (three after meals, one before resting) for another three weeks.
Intervention Type
Device
Intervention Name(s)
Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet
Other Intervention Name(s)
GERDOff Plus
Intervention Description
1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks
Intervention Type
Device
Intervention Name(s)
Placebo 1100 mg, identically-looking melt in mouth tablet
Other Intervention Name(s)
GERDOff Plus placebo
Intervention Description
1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks
Primary Outcome Measure Information:
Title
Overall patient satisfaction
Description
The percentage of patients with an improvement of at least 2 points in the patient satisfaction measured with a 1 to 5 Likert scale (1 worst satisfaction, 5 best satisfaction)
Time Frame
From baseline to the end of the respective 3-week treatment period
Secondary Outcome Measure Information:
Title
Change of weekly frequency of each symptom using the Gastro Esophageal Reflux Disease Questionnaire (GERDQ) questionnaire
Description
The reduction of weekly frequency score (points) for each symptom (score from 0 to 3, where higher scores mean a worse outcome) assessed by GERDQ questionnaire. Frequency score (points) for symptom: 0=0 day, 1=1 day, 2=2-3 days, 3=4-7 days; How often did you have a burning feeling behind your breastbone (heartburn)? 0 1 2 3 How often did you have stomach contents (liquid or food) moving upwards to your throat or mouth (regurgitation)? 0 1 2 3 How often did you have a pain in the centre of the upper stomach? 3 2 1 0 How often did you have nausea? 3 2 1 0 How often did you have difficulty getting a good night's sleep because of your heartburn and ⁄ or regurgitation? 0 1 2 3 How often did you take additional medication for your heartburn and ⁄ or regurgitation, other than what the physician told you to take? (such as Tums, Rolaids, Maalox?) 0 1 2 3
Time Frame
From baseline to the end of the respective 3-week treatment period
Title
Change of weekly global score of symptoms using the Gastro Esophageal Reflux Disease Questionnaire (GERDQ) questionnaire
Description
The reduction of global score of GERQ questionnaire (score from 0 to 18, where higher scores mean a worse outcome). Global score is obtained as sum score of the 6 items detailed in Outcome 2.
Time Frame
From baseline to the end of the respective 3-week treatment period
Title
Change of the intensity of each symptom using the Reflux Symptom Index (RSI) questionnaire
Description
The reduction of score of each symptom (from 0 to 5, where 0 = No problem and 5 = Severe Problem) assessed by RSI questionnaire Hoarseness or a problem with voice Cleaning throat Excess throat mucus or postnasal drip Difficulty swallowing food, liquids, or pills Coughing after eating or after lying down Breathing difficulties or chocking episodes Troublesome or annoying cough Sensations of something sticking or a lump in the throat Heartburn, chest pain, indigestion or stomach acid coming up
Time Frame
From baseline to the end of the respective 3-week treatment period
Title
Change of the global score using the Reflux Symptom Index (RSI) questionnaire
Description
The reduction of global score of RSI questionnaire (from 0 to 45, where higher scores mean a worse outcome). Global score is obtained as sum score of the 9 items detailed in Outcome 4.
Time Frame
From baseline to the end of the respective 3-week treatment period
Title
Assessment of palatability
Description
The score of taste through a 4-point qualitative scale (where 1 - taste as bad as possible, and 4 - taste as good as possible)
Time Frame
At the end of 3-week treatment period
Title
Evaluation of the intake of rescue medications
Description
The amount of rescue medications taken
Time Frame
From V1 (randomization) to V4 (Day 63 +/- 2 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed and dated informed consent (ICF): a written informed consent must be obtained prior to any study related procedure being performed Male and female out-patients aged 18 to 80 years GERD diagnosis confirmed through a validated questionnaire (GERDQ score ≥ 8). EGD endoscopy performed within 1 year before screening Patients in continuous or intermittent treatment with PPI for at least 1 year and continuously for at least 4 weeks prior to study entry Patients not fully satisfied with current PPI treatment (1-3 score on 5-points Likert scale) Exclusion Criteria: Dyspeptic patients or patients with overlapping symptoms with GI diseases other than GERD Histological evidence of Barrett's oesophagus > 1 cm in EGD endoscopy Peptic stricture in EGD endoscopy Concurrent findings in the EGD endoscopy that might interfere with the participation to the study (e.g cancer, peptic ulcer) as judged by the investigator Known impaired kidney or liver function at screening Presence of any relevant severe condition or clinically relevant abnormal parameters that in the opinion of the investigator may interfere with the participation to the study Medication use (including H2 antagonists, alginates, baclofen, NSAIDS, prokinetics, antidepressants) that may interfere with GERD symptom assessment within 2 weeks before the start of the study or during the study Pregnancy or breast-feeding Females of childbearing potential not employing adequate contraceptive methods Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable) History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements Treatment with any investigational drug within the previous 30 days
Facility Information:
Facility Name
Diakonie Klinikum GmbH - Jung- Stilling Krankenhaus
City
Siegen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
57074
Country
Germany
Facility Name
Klinikum Region Hannover (KRH) Klinikum Siloah
City
Hannover
ZIP/Postal Code
30459
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of a Combination Oral Formulation of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate in Patients With Gastro-Esophageal Reflux Disease Not Fully Satisfied With Their Treatment

We'll reach out to this number within 24 hrs